TriangleNCT03974022 · OUTCOME
Part B: Cmax,ss, at Steady State of DZD9008 and DZ0753
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- ng/mL
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- Cycle 2 Day 1: 0 (predose) up to 24 hours
What was measured
Maximum observed plasma concentration, obtained directly from the observed concentration versus time data. Calculated for the multiple dose.
Analysis population: All dosed participants who have at least one measurable plasma concentration of DZD9008 post dose with no protocol deviations or adverse event thought to impact the analysis of the PK data.
Groups in this outcome
Part B Dose Extension Cohort 1: EGFR exon20ins, Previously Treated; Sunvozertinib 200 mg
Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy. Patients were randomized at a 1:1 ratio to receive sunvozertinib 200 mg once daily continuously.
Part B Dose Extension Cohort 2: EGFR exon20ins, Previously Treated; Sunvozertinib 300 mg
Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy. Patients were randomized at a 1:1 ratio to receive sunvozertinib 300 mg once daily continuously.
| Group | Source count |
|---|---|
| Part B Dose Extension Cohort 1: EGFR exon20ins, Previously Treated; Sunvozertinib 200 mg | 14 |
| Part B Dose Extension Cohort 2: EGFR exon20ins, Previously Treated; Sunvozertinib 300 mg | 9 |
Reported measurements
Part B: Maximum Plasma Concentration (Cmax,ss) of DZD9008
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part B Dose Extension Cohort 1: EGFR exon20ins, Previously Treated; Sunvozertinib 200 mg | 342.8 | 57.4 | Not reported | Not reported | Not reported |
| Part B Dose Extension Cohort 2: EGFR exon20ins, Previously Treated; Sunvozertinib 300 mg | 642.3 | 48.1 | Not reported | Not reported | Not reported |
Part B: Maximum Plasma Concentration (Cmax,ss) of DZ0753
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part B Dose Extension Cohort 1: EGFR exon20ins, Previously Treated; Sunvozertinib 200 mg | 42.58 | 108.0 | Not reported | Not reported | Not reported |
| Part B Dose Extension Cohort 2: EGFR exon20ins, Previously Treated; Sunvozertinib 300 mg | 112.4 | 83.7 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 57.4
- value
- 342.8
- group Id
- OG001
- spread
- 48.1
- value
- 642.3
- title
- Part B: Maximum Plasma Concentration (Cmax,ss) of DZD9008
- categories
- measurements
- group Id
- OG000
- spread
- 108.0
- value
- 42.58
- group Id
- OG001
- spread
- 83.7
- value
- 112.4
- title
- Part B: Maximum Plasma Concentration (Cmax,ss) of DZ0753
- denoms
- counts
- group Id
- OG000
- value
- 14
- group Id
- OG001
- value
- 9
- units
- Participants
- description
- Maximum observed plasma concentration, obtained directly from the observed concentration versus time data. Calculated for the multiple dose.
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy. Patients were randomized at a 1:1 ratio to receive sunvozertinib 200 mg once daily continuously.
- id
- OG000
- title
- Part B Dose Extension Cohort 1: EGFR exon20ins, Previously Treated; Sunvozertinib 200 mg
- description
- Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy. Patients were randomized at a 1:1 ratio to receive sunvozertinib 300 mg once daily continuously.
- id
- OG001
- title
- Part B Dose Extension Cohort 2: EGFR exon20ins, Previously Treated; Sunvozertinib 300 mg
- param Type
- GEOMETRIC_MEAN
- population Description
- All dosed participants who have at least one measurable plasma concentration of DZD9008 post dose with no protocol deviations or adverse event thought to impact the analysis of the PK data.
- reporting Status
- POSTED
- time Frame
- Cycle 2 Day 1: 0 (predose) up to 24 hours
- title
- Part B: Cmax,ss, at Steady State of DZD9008 and DZ0753
- type
- SECONDARY
- unit Of Measure
- ng/mL
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice